Home / Recalls / Precision Dose Inc. / D-0094-2022

D-0094-2022 Class II Terminated

Recalled by Precision Dose Inc. — South Beloit, IL

Recall Details

Product Type
Drugs
Report Date
November 17, 2021
Initiation Date
November 1, 2021
Termination Date
July 14, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
166,920 unit dose cups

Product Description

Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

Reason for Recall

cGMP Deviations: Product manufactured with contaminated raw ingredient.

Distribution Pattern

Nationwide USA

Code Information

Lot#: 503670

Other recalls by Precision Dose Inc.

  • D-0095-2022 Class II — Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup (N (November 1, 2021)
  • D-0228-2021 Class II — Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dos (January 1, 2021)
  • D-1004-2020 Class II — Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case (November 13, 2019)
  • D-0057-2018 Class III — Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-3 (September 25, 2017)
  • D-1037-2017 Class II — Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, P (July 5, 2017)
  • D-250-2013 Class II — Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6809 (March 21, 2013)